BrightGene Fine Chemical Co., Ltd (Tongyuan Road) – FDA 483, Jan 20, 2024
BrightGene Fine Chemical Co. Ltd. in Taizhou, Jiangsu, China, received a Form FDA 483 with six observations following an inspection from January 15-20, 2024. The inspection revealed significant deficiencies across manufacturing process validation, quality unit oversight, laboratory controls, equipment maintenance, and supplier qualification. These issues indicate a systemic failure to adhere to cGMP requirements for intermediates and active pharmaceutical ingredients, with some observations being repeats from previous inspections.
- Inspection date
- January 20, 2024
- Product type
- drugs
ID · 1a955097-0506-44e5-9b78-b9dd4a49ec6e
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.